A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients
1 other identifier
interventional
80
1 country
1
Brief Summary
This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedOctober 21, 2024
October 1, 2024
10 months
July 22, 2024
October 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
ORR
Objective response rate
12 months
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
12 months
Secondary Outcomes (1)
PFS
24 months
Study Arms (4)
SSGJ-707(dose 1)+ carboplatin + paclitaxel
EXPERIMENTALSSGJ-707(dose 2)+ carboplatin + paclitaxel
EXPERIMENTALSSGJ-707(dose 3)+ carboplatin + paclitaxel
EXPERIMENTALSSGJ-707(dose 4)+ paclitaxel
EXPERIMENTALInterventions
SSGJ-707 is a bispecific antibody against human PD-1 and VEGF
chemotherapy
chemotherapy
Eligibility Criteria
You may qualify if:
- Age:18-75 years old
- Advanced endometrial cancer and platinum-resistant ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival \>=12 weeks.
- Signed informed consent form.
You may not qualify if:
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chongqing Cancer Hospital
Chongqing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2024
First Posted
July 26, 2024
Study Start
October 10, 2024
Primary Completion
August 1, 2025
Study Completion (Estimated)
August 1, 2026
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share